ARL places strong emphasis on quality control, proficiency testing and other quality assurance initiatives.ARL participates in a number of external quality control programs.This, combined with an emphasis on employee competency testing assures that ARL results are accurate and reliable.Information on current test methods, including performance specification, is available upon request.

Laboratory Accreditations

College of American Pathologists (CAP) 17882-01

Clinical Laboratory Improvement Amendments (CLIA) 52D0395330

Certified Medicare Provider

Joint Commission

Medicare/Medicaid Compliance

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The CPT codes published in this Reference Manual are provided for informational purposes
only. The codes reflect our interpretation of CPT coding requirements, based upon AMA guidelines
published annually. CPT codes are provided only as guidance to assist you in billing. ARL strongly
recommends that clients confirm CPT codes with their local carrier or intermediary. CPT coding is the
sole responsibility of the billing party. ARL assumes no responsibility for billing errors due to
reliance on the CPT codes listed in this Reference Manual.

ARL offers groups of tests based on accepted clinical practice, as well as those that are defined by
the American Medical Association Current Procedural Terminology (CPT). All individual components of these
“panels” may also be ordered individually, unless otherwise indicated.

A standard reflex test panel allows the physician the option of ordering either the reflex group or a
detail test.

A compulsory reflex panel automatically generates a request for additional testing if the result(s) of
the initial test(s) meets or falls outside certain ranges. In many cases and especially in microbiology
and blood bank procedures, the compulsory reflex test panels have been predetermined based on specific medical
criteria, are accepted as standard-of-care by the medical community, and may not be available for ordering at
the detail level.

Under federal and state statutes and regulations, Aspirus Reference Laboratory (ARL) bills Medicare
and Medical Assistance directly for clinical laboratory services that it performs or refers to an outside
laboratory. Physicians may not bill the Medicare or Medical Assistance programs for laboratory tests they
do not perform. When ordering laboratory tests that will be billed to Medicare / Medicaid or any other
federally funded program, the following requirements apply:

Only tests that are medically necessary for the diagnosis or treatment of the patient
should be ordered. Medicare does not pay for screening tests, except for certain specifically
approved procedures, and may not pay for tests considered experimental or not approved by FDA. The Office
of the Inspector General takes the position that a physician who orders medically unnecessary testing may be
subject to civil penalties.

If there is reason to believe that Medicare will not pay for a test, the patient must be
informed and asked to sign an Advance Beneficiary Notice (ABN) to indicate that he/she is responsible for the
cost of the test if Medicare denies payment.

The ordering physician is required to provide ICD-10 diagnosis codes to laboratories to ensure
that laboratory claims will be accurate. Please provide an ICD-10 code that most accurately describes the
patient’s condition. Do not choose a code merely to claim payment. ICD-10
codes must be provided in a valid format, including the fourth and fifth digit specificity when required and
available.

Local Coverage Determinations (LCD) and National Coverage Determinations (NCD) exist for many
laboratory tests. The NCDs are found on the CMS website at https://www.cms.gov/. LCDs are listed on the websites of
the carrier or fiscal intermediary. It is the responsibility of the client to verify CPT codes
and ICD-10 codes with Medicare carriers and third party payers.

Whenever possible, tests that are subject to LCDs or NCDs as established by Aspirus Reference
Laboratory’s fiscal intermediary are printed in red on ARL test requisition forms.

Organ and disease related panels should be ordered only when all components of the panel are
medically necessary.

Medicare National Limitation Amounts for CPT codes are available from the Centers for Medicare
and Medical Assistance web site (www.cms.hhs.gov/coverage) or
its intermediaries. Medicaid reimbursement will be equal to or less than the amount of Medicare
reimbursement.

Aspirus Reference Laboratory files claims with the Medicare and Medical Assistance programs for
referred tests for patients insured by these programs. If Medicare or Medical Assistance is secondary to
other insurance, ARL will file claims with the primary insurer.

To insure accurate and timely filing of Medicare and Medical Assistance claims, the following
information is required. We recognize the extra time and effort it takes to provide this additional
information to us and we are grateful for your continued cooperation in helping us obtain the information we
need to bill for our services.

A copy of your facility’s patient demographic and complete billing information may be attached
to the requisition as a means of providing the following information:

In the event that a test is determined by ARL’s Medicare fiscal intermediary to be medically
unnecessary, the laboratory may only bill the patient if an Advance Beneficiary Notice (ABN) has been
completed and signed by the patient prior to the time that the specimen is collected. The ABN is a
three-part form available from ARL. Please see page 13 for information on completion of a valid
ABN. Clients who have access to the Aspirus information system network are encouraged to use the ABN
Compliance Checker to determine medical necessity and generate ABNs. The original ABN is submitted to ARL
with the specimen for testing.

Medicare’s medical necessity requirements may not always be consistent with the reasons you
believe a test is appropriate for a patient. Nevertheless, when you have reason to believe that Medicare
may consider a test medically unnecessary, the patient should be asked to sign a completed ABN after receiving
a clear explanation of the reason(s) the ABN is necessary. A new original ABN must be signed each time
such conditions exist. An ABN signature may not be requested solely on the basis that a test being
ordered is subject to coverage limitations under an LCD or NCD.

The ABN and your explanation ensure that the patient understands that he/she will be responsible to
pay for any service marked on the form that Medicare does not cover for one of the following reasons:

The test is subject to coverage limitations and the diagnosis for which the test is ordered is
not considered to be indicative of medical necessity by Medicare.

No diagnosis was provided.

The test is ordered more frequently than Medicare considers medically necessary.

The test is for research or investigational use only and is not approved by the Food and Drug
Administration.

An Advance Beneficiary Notice may only be obtained when the laboratory or physician believes a test
may not be covered. ABNs must not be obtained from every Medicare beneficiary (blanket ABN).

An ABN is not required for screening services or services that Medicare does not cover. However,
the ABN is highly recommended because the patient must be informed that Medicare does not provide coverage for
screening diagnoses or for a particular service.

If Medicare denies reimbursement for a test and a valid ABN has not been obtained, the client
will be billed for the test at the client’s fee schedule rate.

All of the information on the Advance Beneficiary Notice form must be
completed. The test(s) that you believe will be considered by Medicare to be medically
unnecessary must be clearly marked. The reason for possible denial of payment must also be
indicated. Please write the test name and CPT code as they appear in ARL’s test request form,
reference manual or Misys function MIQ. Do not use synonyms or abbreviations.

Please be sure that the patient reads, understands and signs the ABN prior to the specimen being
collected. If the patient is unable to sign, the form should be marked with an “X” and the
patient’s guardian, guarantor or other responsible party should sign the form.